CN106170306B - A dual migration indicator - Google Patents

Abstract

An indicator for a sterilization process configured to operate under two different sterilization conditions. The indicator includes two passing areas to indicate that acceptable sterilization has occurred after a sterilization process of a first sterilization condition or after a sterilization process of a second sterilization condition.

Description

A dual migration indicator

technical field

An indicator for sterilization.

Background technique

It is well known that heat destroys microbes. The presence of moisture can accelerate this destruction by denaturation or coagulation of the proteins that make up the microorganism. Most microorganisms contain enough water that moderate heat alone, such as 80°C to 100°C, destroys the microorganisms. On the other hand, many bacterial spores are substantially free of water and are destroyed only at high temperatures in excess of 150°C, so dry heat destruction is used. Therefore, destruction of such organisms is usually carried out in the presence of steam in an autoclave.

Such steam sterilization is typically performed at a temperature of about 250°F (121°C) for at least 12-15 minutes, or at a higher temperature such as 270°F (132°C) for a shorter period of time. To ensure a sufficient safety margin, a time of up to 30 minutes is usually used. This long sterilization time gives the operator a greater degree of confidence that the steam has penetrated the entire autoclave and all components inside it. However, such a long thermal cycle is disadvantageous from the point of view of saving time, energy consumption, and it severely shortens the service life of certain types of sterilization materials, such as fabric gowns, curtains, and the like.

Continued attempts have been made to develop sterilization indicators and there is confidence in the quality control of sterilization that all microorganisms have been destroyed. One method currently used is through the use of spore strips or samples. Particularly hard-to-destruct spores were selected as control criteria, such as Bacillus subtilis var. spores and Bacillus stearothermophilus. Spore strips or samples are placed in an autoclave with the material to be sterilized. At the end of the sterilization cycle, the spore belt or sample is studied to determine if it is possible to grow the organism in a suitable medium. Failure to reproduce spores indicates that the spores have died and, therefore, adequate sterilization.

Although accurate, such control techniques have several inherent disadvantages: (1) cost prohibitive; (2) delays between processing and control data; (3) variability between spore batches; and (4) The heat resistance of spores decreased with storage time.

Several attempts have been made to design chemical-type sterilization indicators. One such product is known as a Temp-Tube, which is disclosed in, for example, Kelson, US Pat. No. 3,313,266; White, US Pat. No. 3,341,238, and White, US Pat. No. 3,652,249. The device includes a sealed tube containing a compound having a melting point corresponding to the sterilization temperature. The device is capable of indicating whether the autoclave is maintained at a temperature above or below the melting point for a period of time once the melting point is reached.

Other known sterilization indicators. One such indicator is disclosed in Larsson, US Pat. No. 3,981,683, which uses an aluminum foil backing sheet with an organic compound containing oxygen or nitrogen in contact with the wicking strip, and a cover covering the organic compound with the wicking strip strip. The cover strip is a polymeric rate-controlling film that allows water vapor to pass through at a velocity sufficient to make the cover strip operable at monitored temperatures.

One disadvantage of the Larsson device is that the temperature and time parameters of the indicator indicating acceptable levels of sterilization are not well controlled (eg, the temperature has been kept at a minimum for a specified period of time). Likewise, the indicator indicates that a necessary level of sterilization has occurred when it has not actually occurred.

Another such indicator is disclosed in Foley, US Pat. No. 4,448,548. The Foley device refers to a steam sterilization indicator in which a fusible material in tablet form is deposited in an embossing of an aluminum backing. A wicking tape is attached to the backing adjacent to the meltable tablet. A clear plastic material covers the tablet and wicking tape and adheres to the backing.

The melting point of fusible tablets is lowered in the presence of saturated steam. Approaching melting, the material in the tablet is absorbed by the wicking belt, producing a colored front to provide an integrated indication of time and temperature in the presence of steam. Different amounts of binder are used in the tablet to provide a device that can be adjusted to reflect the thermal lethality profile of different types of microorganisms. The cover and wicking tapes are bonded to the backing by an acrylic adhesive that also affects the rate of the indicator.

The disadvantage of the Foley device, like the Larsson device, is that the temperature and time parameters of the indicator indicating acceptable levels of sterilization are not well controlled. Likewise, the indicator indicates that a necessary level of sterilization has occurred when it has not actually occurred.

In addition, US Patents US 13/031491 and US 13/432807, assigned to the applicant of the present application and the contents of which are incorporated herein by reference, disclose sterilization test strips in the sense that Mimics spore killing. These test strips are configured to indicate whether acceptable levels of sterilization have occurred after a predetermined time at a predetermined temperature. For example, a test strip can be configured to indicate an acceptable level of sterilization after 4 minutes at 134°C. However, these test strips are configured to work under a specific sterilization condition (eg, 4 minutes at 134°C). Therefore, a different test strip is required for each different sterilization condition. For example, a test strip configured to work under sterilization conditions of 134°C for 4 minutes will not be effective under sterilization conditions of 121°C for 12 minutes, therefore, a different test strip is required for the latter sterilization conditions. Likewise, users performing sterilization processes with many different conditions are forced to purchase and stock many different test strips, which increases operating costs and leads to user errors in selecting the correct indicator.

Test strips for two different sterilization conditions were also introduced. However, these test strips are configured with two different chemical indicators for each sterilization condition. Therefore, these test strips essentially combine two test strips into one test strip, which are therefore bulky and expensive.

Therefore, there is an urgent need for an improved sterilization indicator for a variety of sterilization conditions.

SUMMARY OF THE INVENTION

Dual indicators for sterilization are configured to work under two different sterilization conditions. The dual indicator includes two pass-through areas, each of which is configured to indicate whether acceptable sterilization has occurred after a different sterilization condition. In this way, the dual indicator can replace two different 6-level sterilization indicators, which can reduce the number of different test indicators required by the user.

In one aspect, a dual indicator is provided for use under two different sterilization conditions. The dual indicator includes a base member, a first adhesive layer, a chemical indicator composition, a wicking material, a film layer, a second adhesive layer, a paper layer, and first and second passage areas. The base element is formed of a thermally conductive material having a length and a width. The base element has a recess formed therein extending approximately along a longitudinal centerline of the base element, wherein the recess is formed within the base material with a length and width less than that of the base material. A first adhesive layer is disposed on the base member, and a chemical indicator composition is deposited in the recesses.

The wicking material is placed at least partially in contact with the chemical indicator composition and placed at least partially within the recess. The wicking material extends in a length and width that is less than that of the base element. The thin film layer is placed over the base member, wicking material and chemical indicator composition. Furthermore, the paper layer is placed over the film layer, and a second adhesive layer is placed between the paper layer and the film layer. The paper layer and the second adhesive layer include windows disposed therein. The dual indicator also includes a first passage area and a second passage area configured to indicate whether an acceptable level of sterilization has occurred under two different sterilization conditions.

The dual indicator is configured to indicate that an acceptable level of sterilization has occurred, at a first predetermined temperature, after a first predetermined period of sterilization treatment, when the chemical indicator composition wicks along the wicking material to a first When passing through a location within the area, or at a second predetermined temperature, after sterilization for a second predetermined period of time, when the chemical indicator composition is wicked along the wicking material to a location within the second passage area location.

In one embodiment, the chemical indicator composition contains a temperature sensitive material. Additionally, the chemical indicator composition may contain dyes. For example, the chemical indicator composition contains a temperature sensitive material and a dye at a concentration of about 0.01% by weight of the chemical indicator composition.

Additionally, the film may be formed from cast polypropylene, such as cast polypropylene having a thickness of about 2.0-2.2 mils or a thickness of about 3.0-3.2 mils. The base member may be formed of aluminum having a thickness of about 3 mils.

In some embodiments, the first adhesive layer is formed of an acrylic adhesive, and the second adhesive layer can also be formed of an acrylic adhesive.

Additionally, the paper layer includes a first indicia and a second indicia, wherein the first indicia is longitudinally spaced from the chemical indicator composition by a first distance therebetween, and the second indicia is longitudinally spaced from the chemical indicator composition is spaced apart from the chemical indicator composition by a second distance therebetween. In such an embodiment, the second distance is greater than the first distance. The first pass area is defined by the position of the first mark and the area beyond the first mark, and the second pass area is defined by the second mark and the area beyond the second mark.

In one embodiment, the first predetermined temperature is 121°C, and the first predetermined time period is selected from 12 minutes, 15 minutes and 20 minutes. In such an embodiment, when the chemical indicator composition is wicked along the wicking material to a location within the first passage zone after a sterilization treatment at 121°C for 12 minutes, 15 minutes or 20 minutes , the dual indicator is configured to indicate that an acceptable level of sterilization has been achieved.

In addition, the second predetermined temperature is 132° C., and the second predetermined time period may be 4 minutes. In such an embodiment, the dual indicator is configured when the chemical indicator composition is wicked along the wicking material to a location within the second passage zone after 4 minutes of sterilization at 132°C successfully indicates that an acceptable level of sterilization has been achieved.

In another embodiment, the second predetermined temperature is 134°C, and the second predetermined time period is selected from 3.5 minutes, 4 minutes, 5 minutes and 7 minutes. In such an embodiment, when the chemical indicator composition is wicked along the wicking material to a certain point within the second passage zone at 134°C for 3.5 minutes, 4 minutes, 5 minutes or 7 minutes In one position, the dual indicator is configured to indicate that an acceptable level of sterilization has been achieved.

In yet another embodiment, the second predetermined temperature is 135°C, and the second predetermined time period is 3 minutes. In such an embodiment, the dual indicator is configured when the chemical indicator composition is wicked along the wicking material to a location within the second passage zone after 3 minutes of sterilization at 135°C successfully indicates that an acceptable level of sterilization has been achieved.

The above and other features and advantages of the indicators of the present invention will be apparent from the following detailed description, taken in conjunction with the claims.

Description of drawings

To those skilled in the art, the benefits and advantages of the apparatus of the present invention will become more apparent from the following detailed description and accompanying drawings, wherein:

1 is a top plan view of a dual indicator according to an embodiment;

Figure 2 is a cross-sectional view along 2-2 of the dual indicator shown in Figure 1; and

3 is a top perspective view of the dual indicator shown in FIG. 1 with a paper layer, a second adhesive layer, and a peeled film layer.

Detailed ways

The device of the present invention can be implemented in various forms. The preferred embodiment as shown in the drawings and the following disclosure of the present invention is only an exemplary embodiment of the device, and the protection scope of the present invention should not be limited. in specific examples.

It should be further understood that the title of this section of the specification, "Detailed Description of the Invention", in relation to the requirements of the US Patent Office, is not intended, and should not be inferred, to limit the subject matter of the present invention.

Referring to Figures 1-2, one embodiment of a dual indicator 10 is shown. Dual indicator 10 has an open window 12 through which wicking of chemical indicator composition 14 can be observed to determine if acceptable levels of sterilization have occurred as described below. As shown, the dual indicator 10 includes two passage areas 32, 34 for indicating whether acceptable levels of sterilization have occurred under two different sterilization conditions. For example, the dual indicator 10 can be configured to operate either under sterilization conditions of 12 minutes at 121°C or sterilization conditions of 4 minutes at 134°C. The first pass area 32 is defined by the location of the first mark 36 and the area beyond the first mark 36 . The second pass area 34 is defined by the second mark 38 and the area beyond the second mark 38 . Dual indicators 10 are configured in various lengths and widths. For example, dual indicator 10 may be configured to have a length of about 2 inches to about 5 inches, preferably about 2.5 inches to about 4 inches, and more preferably about 3 inches, and a width of about 5/8 inches to about 1 inch, preferably is about 3/4 inch.

FIG. 2 is a cross-sectional view of the dual indicator 10 shown in FIG. 1 . The dual indicator 10 generally includes a base member 16 , a first adhesive layer 22 , a wicking member 20 , a film layer 26 , a second adhesive layer 30 , a paper layer 28 and a chemical indicator composition 14 . The base element 16 is formed from a metal foil, eg, aluminum foil or other highly thermally conductive material. The first adhesive layer 22 is disposed on the base element 16 as a continuous layer that covers substantially the entire top surface of the base element 16 . The base element 16 has a length L16 and a width W16. Recesses 18 are formed within base element 16 and first adhesive layer 22 . The chemical indicator composition 14 is disposed in the recess 18 between the first adhesive layer 22 and the wicking element 20 .

The wicking element 20 is disposed on the first adhesive layer 22 over the chemical indicator composition 14 such that the wicking element 20 is in contact with the chemical indicator composition 14 . FIG. 3 is a top perspective view of dual indicator 10 with film layer 26 , second adhesive layer 30 and peeled paper layer 28 . As shown, the wicking element 20 has a width W20 and a length L20 that are smaller than the width W16 and length L16 of the base element 16, respectively. For example, the wicking element 20 is configured to have a width W20 of about 1/8 inch to about 3/8 inch, preferably about 1/4 inch, while the base element 16 is configured to have a width of about 5/8 inch to about 1 inch Width W16, preferably about 3/4 inch. The wicking element 20 is generally centrally located on the base element 16 and positioned over the chemical indicator composition 14 within the recess 18 so that the end 42 of the wicking element 20 is in contact with the chemical indicator composition 14 . The wicking element 20 extends longitudinally of the base element 16 such that at least some portions of the wicking element are firmly adhered to the base element 20 by the first adhesive layer 22 . In this manner, chemical indicator composition 14 and wicking element 20 are bounded by four sides within dual indicator 10 .

Thin film layer 26 is applied over base element 16 , chemical indicator composition 14 , and wicking element 20 and is adhered to base element 16 by first adhesive layer 22 . As described in detail below, the thin film layer 26 is a transparent film. The paper layer 28 and the second adhesive layer 30 are disposed over the film layer 26 . The paper layer 28 and the second adhesive layer 30 include a window 12 (see FIG. 1 ) that is cut out to allow visual inspection of the film layer 26 within the window 12 .

In one embodiment, the base member 16 is made of aluminum foil, and an acrylic adhesive layer is coated on the base member 16 to form the first adhesive layer 22 . In some embodiments, foil adhesive labels having a thickness of 3/1000 inch (3 mils) may be used to form the base member 16 and the first adhesive layer 22 . Additionally, adhesive coated paper may be used to form paper layer 28 and second adhesive layer 30 . For example, acrylic adhesive-coated paper may be used to form paper layer 28 and second adhesive layer 30 . The film layer 26 may be formed from a cast polypropylene film having a thickness of about 2.0-2.2 mils or 3.0-3.2 mils.

The wicking element 20 may be formed from a suitable wicking material. In some embodiments, the wicking element 20 may be formed from a wicking paper having a basis weight of about 66 g/m2 to about 186 g/m2 and a caliper or thickness of about 7.5 mils to 13.3 mils. For example, the wicking element 20 may be formed from a low ash qualitative paper having a basis weight of about 66 g/m2 and a thickness of about 7.3 mils, or from a low ash qualitative paper having a basis weight of about 87.7 g/m2 and a thickness of about 7.5 mils Qualitative paper or tissue paper having a white smooth surface with a basis weight of about 186 g/m2 and a thickness of about 13.3 mils. The chemical indicator composition 14 may be formed from a temperature sensitive chemical composition. The chemical indicator composition may also contain a colorant at a concentration of about 0.01% by weight.

The passage areas 32, 34 are provided on the dual indicator 10 so that the passage areas 32, 34 are visually visible to the user. For example, the pass-through areas 32 , 34 may be provided on the paper layer 28 . The first pass area 32 is defined by the location of the first mark 36 and the area beyond the first mark 36 . The second pass area 34 is defined by the second mark 38 and the area beyond the second mark 38 . During use, during the sterilization process, the chemical indicator composition liquefies and wicks along the wicking material 20 when it is exposed to steam. At the conclusion of the sterilization process, the user observes through window 12 how far the liquefied chemical indicator composition 14 has traveled along the wicking material 20 to determine if an acceptable level of sterilization has occurred.

For example, after sterilization at a first predetermined temperature for a first predetermined period of time (eg, 12 minutes at 121° C.), the user may determine whether the chemical indicator composition 14 has reached the first pass zone 32 by checking whether the An acceptable level at which sterilization occurs. That is, if the chemical indicator composition 14 has reached or exceeded the first mark 36, an acceptable level of sterilization has occurred after the sterilization process at the first predetermined temperature, for the first predetermined period of time . time at the first predetermined temperature. After sterilization at a second predetermined temperature for a second predetermined period of time (eg, 4 minutes at 134° C.), the user may also determine whether this has occurred by checking whether the chemical indicator composition 14 has reached the second pass zone 34 acceptable level of sterilization. That is, if the chemical indicator composition 14 has reached or exceeded the second mark 38, an acceptable level of sterilization has occurred after the sterilization process at the second predetermined temperature, the second predetermined period of time .

Thus, the markings 36, 38 are drawn at a pre-calculated distance from the chemical indicator composition 14 location according to two different sterilization conditions. In this way, the dual indicator 10 may be used to determine whether acceptable sterilization has occurred after a first predetermined temperature, after a first predetermined period of time, or after a second predetermined temperature, after a second predetermined period of time. In one embodiment, the dual indicator 10 may be configured to operate under a first sterilization condition selected from the group consisting of 121°C for 12 minutes, 121°C for 15 minutes, and a second sterilization condition. 121°C for 20 minutes, 121°C for 30 minutes; the second sterilization conditions are selected from the group consisting of 4 minutes at 132°C, 3.5 minutes at 134°C, 4 minutes at 134°C, 5 minutes at 134°C, 7 minutes at 134°C, 3 minutes at 135°C.

As in the embodiment shown in FIG. 1 , the dual indicator 10 also includes a third route 40 . In this embodiment, the first pass area 32 is defined by the area between the first mark 36 and the second mark 38 , and the second pass area 34 is defined by the second mark 38 and the third route 40 . The first passage area 32 and the second passage area 34 may be colored in different colors to assist the user in visualizing the indicator after the sterilization process. For example, the first pass area 32 is colored light blue, the second pass area 34 is colored dark blue, and the remaining surface of the dual indicator 10 is white. In this embodiment, as shown in FIG. 1 , when the chemical indicator 14 is wicked to a location within the first passage zone 32 , it indicates the possibility of sterilization at a first condition (eg, 121° C. for 12 minutes). acceptance level. Although, the chemical indicator 14 may wick beyond the first passage area 32 and into the second passage area 34, this also represents acceptable sterilization after the sterilization process at the first condition, the sterilization process at the first condition Acceptable levels of post sterilization will generally fall within the first pass zone 32 . Alternatively, the dual indicator 10 may also be used to indicate acceptable levels of sterilization following a sterilization treatment at a second condition (eg, 134°C for 4 minutes), wherein when the chemical indicator 14 is wicked to the first 2 When passing through a location within zone 34, an acceptable level of sterilization is indicated.

In one embodiment, the dual indicator 10 is configured such that the chemical indicator composition 14 wicks past the first marking 36 to the first passage area 32 to indicate that after a first predetermined temperature, a first predetermined period of time The acceptable level of sterilization that has occurred, and the wicking of the chemical indicator composition 14 through the second indicia 38, indicates the acceptable level of sterilization that has occurred after a second predetermined time period at a second predetermined temperature. In this preferred embodiment, the dual indicator 10 is configured such that the chemical composition 14 wicks to a location within the first pass zone 32 and does not wick through the second indicia 38 to indicate that at the first predetermined temperature, An acceptable level of sterilization has occurred after the first predetermined period of time, even if the dual indicator 10 is left in sterilization conditions at the first predetermined temperature for a longer period of time. For example, the dual indicator 10 is configured to indicate an acceptable level of sterilization after 12 minutes at 121°C or after 4 minutes at 134°C, wherein the chemical indicator composition 14 wicks through the first marking 36 to the first passage area A position of 32 to indicate an acceptable level of sterilization after 12 minutes at 121°C, and wicking does not exceed the second mark 38, even if the dual indicator 10 is left at sterilization conditions of 121°C for more than 12 minutes, For example 30 minutes. Thus, this dual indicator 10 may reduce the risk of user confusion as the first sterilization condition is indicated by the chemical indicator composition 14 wicking to a location within the first passage area 32 without exceeding the second marking 38 acceptable level of sterilization.

After a long period of research and development, it has been discovered that the dual indicator 10 can be configured to carefully select the material and thickness of the film layer 26 in conjunction with controlling the wicking rate of the chemical indicator composition 14, which can be based on The desired sterilization conditions are achieved by careful selection of the porosity of the wicking material 20. In one embodiment, the dual indicator 10 is configured to indicate an acceptable level of sterilization after 12 minutes at 121°C or after 4 minutes at 134°C, the dual indicator 10 comprising a base member 16, a first adhesive Composition layer 22, wicking element 20, film layer 26, second adhesive layer 30, paper layer 28, and chemical indicator composition 14, wherein film layer 26 is formed of a cast film having a thickness of about 2.2 mils A polypropylene film was formed, and the wicking element 20 was formed of wicking paper having a basis weight of about 87.7 g/m2 and a thickness of about 7.5 mils. The porosity of the wicking paper is related to the basis weight and thickness of the wicking paper.

The dual indicator 10 may also be configured to operate under different sterilization conditions by adjusting the position of the first marker 36 and the second marker 38 . For example, the dual indicator 10 is configured to operate under different combinations of first and second sterilization conditions, wherein the first sterilization condition is selected from the group consisting of 121°C for 12 minutes, 121°C for 15 minutes, 121°C for 20 minutes The second sterilization conditions are selected from the group consisting of 132°C for 4 minutes, 134°C for 3.5 minutes, 134°C for 4 minutes, 134°C for 5 minutes, 134°C for 7 minutes, and 135°C for 3 minutes.

In this way, the dual indicator 10 can replace two forms of a level 6 sterilization indicator for two different sterilization conditions. The dual indicator 10 meets the performance requirements set by the American National Standards Institute (ANSI)/American Association for Medical Device Testing (AAMI)/International Organization for Standardization (ISO) 11140.

All patents mentioned herein are hereby incorporated by reference and their contents, whether specifically or not, are included in the present disclosure.

In the present invention, the word "a" or "an" will be understood to include both the singular and the plural. Conversely, any reference to a plurality of items shall include the singular where appropriate.

From the foregoing, it will be apparent that many modifications and changes can be made without departing from the true spirit and scope of the novel concepts disclosed herein. It should be understood, however, that the specific embodiments shown in the present invention are not limiting and should not be construed as being within the scope of protection of the present invention. All equivalent replacements and modifications of the present invention fall within the protection scope of the present invention.

Claims (19)

1. An indicator for at least two sterilization conditions, comprising: A base element formed from a thermally conductive material having a length and a width, the base element having a recess formed therein extending along a longitudinal centerline of the base element, the recess being within the base material at a smaller size than the base material. Length and width forming; a first adhesive layer placed on the base element; a chemical indicator composition deposited within the recess; a wicking material positioned at least partially in contact with the chemical indicator composition and positioned at least partially within the recess, the wicking material extending at a length and width less than the base element; a thin film layer placed over the base element, the wicking material and the chemical indicator composition; a paper layer placed on top of the film layer; a second adhesive layer disposed between the paper layer and the film layer, wherein the paper layer and the second adhesive layer include a window disposed therein, a first passage area and a second passage area, It is configured to indicate whether an acceptable level of sterilization has occurred under two different sterilization conditions; wherein the indicator comprises a first indicia and a second indicia, wherein the first indicia is longitudinally spaced from the chemical indicator composition by a first distance therebetween and the second indicia is longitudinally spaced from the chemical indicator composition spaced apart from the chemical indicator composition by a second distance therebetween, wherein the second distance is greater than the first distance, wherein the first passage area is defined by the location of the first mark and the area beyond the first mark , the second passing area is defined by the position of the second mark and the area beyond the second mark, Wherein, at the first predetermined temperature, after the sterilization treatment for the first predetermined period of time, when the chemical indicator composition is wicked along the wicking material to a certain position in the first passage area, or at the second predetermined time When the chemical indicator composition is wicked along the wicking material to a location within the second passage zone after the sterilization treatment for a second predetermined period of time at the temperature, the indicator is configured to indicate that an occurrence has occurred. acceptable level of sterilization. 2. The indicator of claim 1, wherein the chemical composition indicator comprises a temperature sensitive material. 3. The indicator of claim 2, wherein the chemical composition indicator comprises a dye. 4. The indicator of claim 1, wherein the film layer is formed of cast polypropylene. 5. The indicator of claim 4, wherein the cast polypropylene has a thickness of 2.0-2.2 mils. 6. The indicator of claim 4, wherein the cast polypropylene has a thickness of 3.0-3.2 mils. 7. The indicator of claim 1, wherein the base member is aluminum. 8. The indicator of claim 7, wherein the base member is aluminum having a thickness of 3 mils. 9. The indicator of claim 1, wherein the first adhesive layer is formed of an acrylic adhesive. 10. The indicator of claim 1, wherein the second adhesive layer is formed of an acrylic adhesive. 11. The indicator of claim 1, wherein the film layer is formed from cast polypropylene having a thickness of 2.0 to 2.2 mils, or having a thickness of 3.0 to 3.2 mils, the wicking The material is formed from a wicking paper having a basis weight of 66g/ ^m2 to 186g/ ^m2 and a thickness of 7.3 mils to 13.3 mils with a sterilization treatment at 121°C for 12 minutes, 15 minutes or 20 minutes Thereafter, the first indicia is positioned such that the chemical indicator composition wicks along the wicking material to a location within the first passage area above the first indicia to indicate an acceptable level of sterilization. 12. The indicator of claim 1, wherein the film layer is formed from cast polypropylene having a thickness of 2.0 to 2.2 mils, or having a thickness of 3.0 to 3.2 mils, the wicking The material is formed from a wicking paper having a basis weight of 66g/ ^m2 to 186g/ ^m2 and a thickness of 7.3 mils to 13.3 mils, wherein the second mark is set after a sterilization treatment at 132°C for 4 minutes In order for the chemical indicator composition to wick along the wicking material to a location within the first passage area above the second indicia to indicate an acceptable level of sterilization. 13. The indicator of claim 1, wherein the film layer is formed from cast polypropylene having a thickness of 2.0 to 2.2 mils, or having a thickness of 3.0 to 3.2 mils, the wicking The material is formed from a wicking paper having a basis weight of 66 g/ ^m2 to 186 g/ ^m2 and a thickness of 7.3 mils to 13.3 mils, wherein the After the sterilization process, the second marker is positioned such that the chemical indicator composition wicks along the wicking material to a location within the second passage area above the second marker to indicate an acceptable level of sterilization. 14. The indicator of claim 1, the film layer is formed from cast polypropylene having a thickness of 2.0 to 2.2 mils, or having a thickness of 3.0 to 3.2 mils, the wicking material being formed of a A wicking paper having a weight of 66g/ ^m2 to 186g/ ^m2 and a thickness of 7.3 mils to 13.3 mils was formed with the second marking set to be chemically indicative after 3 minutes of sterilization at 135°C The agent composition is wicked along the wicking material to a location within the second passage area above the second indicia to indicate an acceptable level of sterilization. 15. The indicator of claim 1, wherein the indicator has a length of 2.5 inches to 4 inches. 16. The indicator of claim 1, wherein the wicking material is formed from wicking paper having a basis weight of 66 ^g / ^m2 to 186 g/m2. 17. The indicator of claim 1, wherein the wicking material is formed from a wicking paper having a thickness of 7.3 mils to 13.3 mils. 18. An indicator for at least two sterilization conditions, comprising: A base element formed from a thermally conductive material having a length and a width, the base element having a recess formed therein extending along a longitudinal centerline of the base element, the recess being within the base material at a smaller size than the base material. Length and width forming; a first adhesive layer placed on the base element; a chemical indicator composition deposited within the recess; a wicking material positioned at least partially in contact with the chemical indicator composition and positioned at least partially within the recess, the wicking material extending at a length and width less than the base element; a thin film layer placed over the base element, the wicking material and the chemical indicator composition; a paper layer placed on top of the film layer; a second adhesive layer disposed between the paper layer and the film layer, wherein the paper layer and the second adhesive layer include a window disposed therein, a first passage area and a second passage area, which is configured to indicate whether an acceptable level of sterilization has occurred under two different sterilization conditions; wherein the indicator comprises a first indicia and a second indicia, wherein the first indicia is longitudinally spaced from the chemical indicator composition by a first distance therebetween, and the second indicia is longitudinally spaced from the chemical indicator composition spaced apart from the chemical indicator composition by a second distance therebetween, wherein the second distance is greater than the first distance, wherein the first passage area is defined by the location of the first mark and the area beyond the first mark , the second passage area is defined by the position of the second mark and the area beyond the second mark, at the first predetermined temperature, after the sterilization treatment for the first predetermined period of time, when the chemical indicator composition wicks along the When the material is wicked to a location within the first passage area, or at a second predetermined temperature for a second predetermined period of time after sterilization, when the chemical indicator composition is wicked along the wicking material to a second The indicator is configured to indicate an acceptable level of sterilization that has occurred upon passage through a location within the zone, the film layer is formed of cast polypropylene having a thickness of 2.2 mils, the wicking material Formed from wicking paper having a basis weight of 66 g/m ² and a thickness of 7.3 mils. 19. The indicator according to claim 18, wherein the first predetermined temperature is 121°C, the first predetermined time period is 12, 15, 20 or 30 minutes, and the second predetermined temperature is 132°C, and the second predetermined time period is 4 minutes.